WASHINGTON, DC, USA I December 22, 2015 I Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that its Marketing Authorization Application (MAA) for oral Fanaptum® tablets has been accepted for evaluation by the European Medicines Agency (EMA) for the treatment of schizophrenia in adults.
“The MAA validation demonstrates Vanda’s commitment to offer another option to the healthcare community to treat a severe, disabling mental disorder,” said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. “This continues our efforts to expand the availability of iloperidone to people who we believe would benefit from this treatment option.”
The MAA is primarily supported by data from two placebo- and active-controlled clinical trials and one long term randomized clinical trial. Fanaptum® was shown to be superior to placebo in controlling symptoms of schizophrenia.
Iloperidone is currently approved in the U.S. as Fanapt® for the treatment of schizophrenia in adults. Fanapt® is also approved and marketed in Israel and Mexico.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. For more on Vanda, please visit www.vandapharma.com.
About Fanapt®
Fanapt® is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. In choosing among treatments, prescribers should consider the ability of Fanapt® to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate Fanapt® slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.
IMPORTANT WARNINGS and PRECAUTIONS: increased mortality in elderly patients with dementia-related psychosis; QT prolongation; neuroleptic malignant syndrome; tardive dyskinesia; hyperglycemia and diabetes mellitus; weight gain; seizures; orthostatic hypotension and syncope; leukopenia, neutropenia and agranulocytosis; hyperprolactinemia; body temperature regulation; dysphagia; suicide; priapism; potential for cognitive and motor impairment.
COMMONLY OBSERVED ADVERSE REACTIONS of FANAPT® (>=5% and 2x placebo): dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.
For full U.S. Prescribing Information, including Boxed Warnings and Important Safety Information, visit our Web site at www.fanapt.com.
SOURCE: Vanda Pharmaceuticals
Post Views: 113
WASHINGTON, DC, USA I December 22, 2015 I Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced that its Marketing Authorization Application (MAA) for oral Fanaptum® tablets has been accepted for evaluation by the European Medicines Agency (EMA) for the treatment of schizophrenia in adults.
“The MAA validation demonstrates Vanda’s commitment to offer another option to the healthcare community to treat a severe, disabling mental disorder,” said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. “This continues our efforts to expand the availability of iloperidone to people who we believe would benefit from this treatment option.”
The MAA is primarily supported by data from two placebo- and active-controlled clinical trials and one long term randomized clinical trial. Fanaptum® was shown to be superior to placebo in controlling symptoms of schizophrenia.
Iloperidone is currently approved in the U.S. as Fanapt® for the treatment of schizophrenia in adults. Fanapt® is also approved and marketed in Israel and Mexico.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. For more on Vanda, please visit www.vandapharma.com.
About Fanapt®
Fanapt® is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. In choosing among treatments, prescribers should consider the ability of Fanapt® to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate Fanapt® slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration.
IMPORTANT WARNINGS and PRECAUTIONS: increased mortality in elderly patients with dementia-related psychosis; QT prolongation; neuroleptic malignant syndrome; tardive dyskinesia; hyperglycemia and diabetes mellitus; weight gain; seizures; orthostatic hypotension and syncope; leukopenia, neutropenia and agranulocytosis; hyperprolactinemia; body temperature regulation; dysphagia; suicide; priapism; potential for cognitive and motor impairment.
COMMONLY OBSERVED ADVERSE REACTIONS of FANAPT® (>=5% and 2x placebo): dizziness, dry mouth, fatigue, nasal congestion, orthostatic hypotension, somnolence, tachycardia, and weight increased.
For full U.S. Prescribing Information, including Boxed Warnings and Important Safety Information, visit our Web site at www.fanapt.com.
SOURCE: Vanda Pharmaceuticals
Post Views: 113
